Colorectal carcinoma is the most common gastrointestinal malignancy affecting about 160,000 new cases per year in the United States. Survival rates are closely related to the stage of cancer at the time of diagnosis. Novel approaches for the detection of colon cancer in the early stages by non-invasive methods are critically needed for secondary prevention by mass screening of high risk populations. The new emerging science of COPROCYTOBIOLOGY, involving the isolation of colonic epithelial cells from stool and screening these cell populations for tumor cells carrying cancer-specific markers is an exciting development. This new technology is still a research tool, although a number of publications have appeared showing its usefulness in early cancer diagnosis. The objective of this SBIR, is to standardize the technology, develop prototype kits for the collection of samples and introduce in kit form a simplified high throughput procedure which can be readily adopted by clinical laboratories in a cost effective manner. In optimizing the components of the kits, the outcome variables will be cell yield, viability, and retention of cell surface markers. A standard reference marker will be designated for quality control and data reduction when comparing results from several centers. The transport medium for the sample collection kit will be a solution containing the appropriate preservatives and chemical constituents to keep the colonic cells intact and functional. The high throughput procedure will be modifications of published methodologies, eliminating time consuming steps, and providing carefully pre prepared media for size/density based separations involving readily available benchtop laboratory centrifuges. PROPOSED COMMERCIAL APPLICATIONS: If a standardized kit becomes available for isolating colonic cells noninvasively, it would be an attractive and cost effective approach to the early detection of colon cancer and other colonic diseases. Diagnostic laboratories, research centers, biology labs and oncology research centers will be potential users.